A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based antiretroviral therapy

@article{Lalezari2003API,
  title={A phase II clinical study of the long-term safety and antiviral activity of enfuvirtide-based antiretroviral therapy},
  author={Jacob P. Lalezari and Joseph J. Eron and Margrit Carlson and Calvin J. Cohen and Edwin Dejesus and Roberto C. Arduino and Joel Gallant and Paul A. Volberding and Robert Leo Murphy and Fred T. Valentine and Emily L Nelson and Prakash Rao Sista and Alex Dusek and J. Michael Kilby},
  journal={AIDS},
  year={2003},
  volume={17},
  pages={691-698}
}
Objectives: The primary objective was to determine the long-term safety of the subcutaneous self-administration of enfuvirtide. Secondary objectives included the determination of enfuvirtide pharmacokinetics and antiviral activity and the immunological response to the enfuvirtide-containing regimen. Methods: A multicenter 48-week uncontrolled open-label rollover study was conducted on 71 HIV-infected adults recruited from previous enfuvirtide clinical trials. Patients with extensive previous… 
The safety, plasma pharmacokinetics, and antiviral activity of subcutaneous enfuvirtide (T-20), a peptide inhibitor of gp41-mediated virus fusion, in HIV-infected adults.
TLDR
Dose-related decreases in viral load were observed, with a maximum mean reduction from baseline of 1.6 log(10) copies/ml (p< 0.001) seen in the 100 mg bid SC group.
Safety, tolerability, and plasma pharmacokinetics of high-strength formulations of enfuvirtide (T-20) in treatment-experienced HIV-1-infected patients.
  • D. Wheeler, J. Lalezari, M. Salgo
  • Medicine, Biology
    Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
  • 2004
Enfuvirtide: A Novel Agent for the Treatment of HIV-1 Infection
TLDR
Enfuvirtide is an effective treatment option for HIV-1–infected individuals when used in combination with other antiretroviral agents and may be used as part of a regimen for treatment-experienced patients.
Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia.
TLDR
The addition of enfuvirtide to an optimized background regimen provided significant viral suppression and immunologic benefit over a 24-week period in HIV-1-infected patients who had previously received multiple antiretroviral drugs.
Efficacy and Safety of 48 Weeks of Enfuvirtide 180 mg Once-Daily Dosing Versus 90 mg Twice-Daily Dosing in HIV-Infected Patients
TLDR
The antiviral efficacy, safety, and tolerability of 180mg ENF qd appeared comparable with that of 90 mg ENF bid at Week 48, although the study was not powered to demonstrate the noninferiority of once daily versus twice daily.
A Prospective Clinical and Pathological Examination of Injection Site Reactions with the HIV-1 Fusion Inhibitor Enfuvirtide
TLDR
Results suggest that injection technique, injection volume and peptide may influence ISR to ENF, and this study was the first to suggest this.
Influence of subcutaneous injection site on the steady-state pharmacokinetics of enfuvirtide (T-20) in HIV-1-infected patients.
  • J. Lalezari, I. Patel, T. Kinchelow
  • Medicine
    Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
  • 2003
Durable Efficacy of Enfuvirtide Over 48 Weeks in Heavily Treatment-Experienced HIV-1-Infected Patients in the T-20 Versus Optimized Background Regimen Only 1 and 2 Clinical Trials
TLDR
These data demonstrate durable efficacy of enfuvirtide plus an optimized background (OB) of antiretrovirals with OB alone in treatment-experienced HIV-1-infected patients over 48 weeks.
Pharmacokinetics, pharmacodynamics and safety of once-daily versus twice-daily dosing with enfuvirtide in HIV-infected subjects
TLDR
Administration of enfuvirtide 180 mg QD results in bioequivalence compared with 90 mg BID based on AUC with a similar short-term safety profile, but a trend towards a weaker antiretroviral effect.
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